Article

27 Mar 2014,
Erik Vollebregt
A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between…

Article

11 Nov 2013,
Erik Vollebregt
The EU market for medical devices is not fully harmonized, which means that you cannot rely on a medical device being a medical device everywhere in the EU. That, essentially, is what…

Article

11 Oct 2013,
Erik Vollebregt
The ENVI vote results that have already been hotly debated and opined upon are now finally out in the form of a draft European Parliament legislative resolution that the Parliament will vote…

Article

19 Aug 2013,
Erik Vollebregt
The scope of the concept of medical device is in constant flux. The EU amended the definition slightly in 2007 to accomodate for standalone software as medical device, the GHTF changed its…

Article

26 Nov 2012,
Erik Vollebregt
Last week the EU Court decided Brain Products / BioSemi, one of the pending borderline cases involving demarcation between medical devices and ‘general stuff’. This case is interesting and important because it…

Article

26 Sep 2012,
Erik Vollebregt
Today was a big day with a half hour press conference by Commissioner Dalli (for Twitter summaries see here and here) to festively launch the two much anticipated EU medical devices regulation proposals (one for general medical devices,…

Article

04 Apr 2011,
Erik Vollebregt
Traditionally the borderlines between different categories of regulated products (medicinal products, medical devices, food, cosmetics, etc.) have been looked at as strict lines. More and more however it becomes evident that although…